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A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

NCT01069094 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-06-30

No results posted yet for this study

Summary

A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.

Conditions

  • Uterine Leiomyomata

Interventions

DRUG

Progenta

12.5 mg, administered as a once daily oral dose for 90 days.

DRUG

Progenta

25 mg, administered as a once daily oral dose for 90 days.

DRUG

Progenta

50 mg, administered as a once daily oral dose for 90 days.

DRUG

Lucron Depot

3.75 mg IM monthly

DRUG

Placebo

Administered as a once daily oral dose for 90 days.

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Wiehle, PhD · Repros Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2005-01-31
Completion
2005-01-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01069094 on ClinicalTrials.gov